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Table 2 Efficacy results (ITT population)

From: Phase II study of lapatinib in combination with vinorelbine, as first or second-line therapy in women with HER2 overexpressing metastatic breast cancer

Characteristic

Lapatinib + vinorelbine (N=44)

Investigator assessed Overall Response Rate (ORR)

 Overall response rate (CR+PR), n (%)

18 (41)

 (95% CI)

(26.4, 55.4)

Best response, n (%)

 

 Complete response (CR)

4 (9)

 Partial response (PR)

14 (32)

 Stable disease (SD)

14 (32)

 Progressive disease (PD)

5 (11)

 Unknown

7 (16)

Investigator assessed Progression-Free Survival (PFS)

Patients, n (%)

 

 Progressed or died due to any cause *

29 (66)

 Censored, follow-up ended

15 (34)

Kaplan-Meier estimate for PFS (weeks)

 

 Median (95% CI)

24.1 (16.9, 36.7)

Time to response (TTR)

Patients, n (%)

18 (100)

Kaplan-Meier estimate for TTR (weeks)

 

 Median (95% CI)

7.5 (7.1, 8.1)

Duration of Response (DoR)

Patients, n (%)

18 (100)

 Progressed or died due to any cause

13 (72)

 Censored, follow-up ended

5 (28)

Kaplan-Meier estimate for DoR (weeks)

 

 Median (95% CI)

32.0 (18.0, 42.3)

  1. *All deaths were due to breast cancer, therefore progression-free survival and time to progression (TTP) were the same.
  2. CI, confidence interval.